MAUDE Adverse Event Report: DEPUY FRANCE SAS ¿ 3003895575 CORAIL2 STD SIZE 18; HIP FEMORAL STEM/SLEEVE

Catalog Number	3L92518
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	02/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
On (b)(6) 2017: medical records received.After review of the medical records for mdr reportability, revision notes stated large intra-articular effusion, intra-articular metallosis, minimal bone loss, large intra-osseous solid bone cyst.Pathology report showed irregular firm brown tissue.Clinical notes reported pain, discomfort, swelling, intermittently limp, minimal tenderness, serum cobalt is above 7ppb.Part and lot information were provided.This complaint was updated on: aug 8, 2017.
Additional Manufacturer Narrative
Jul 4, 2017: medical records received.After review of the medical records for mdr reportability, revision notes stated large intra-articular effusion, intra-articular metallosis, minimal bone loss, large intraosseous solid bone cyst.Pathology report showed irregular firm brown tissue.Clinical notes reported pain, discomfort, swelling, intermittently limp, minimal tenderness, serum cobalt is above 7ppb.Part and lot information were provided.This complaint was updated on: aug 3, 2017.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 18
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY FRANCE SAS ¿ 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex, rhone alpes 69801 ; FR 69801
• MDR Report Key: 6766074
• Report Number: 1818910-2017-22230
• Device Sequence Number: 16570931
• Product Code: KWA
• UDI-Device Identifier: 10603295168836
• UDI-Public: 10603295168836
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3L92518
• Device Lot Number: 1213250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 10/08/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR